Functional Impact of Acute Respiratory Viral Infections in Older Adults (AFIRI)

Assessment of Functional Impact of Acute Respiratory Viral Infections in Older Adults - An International Multi-center Study

The prevention of infectious diseases in older adults remains a major public health challenge, as acute respiratory infections are a leading cause of hospitalisation, mortality, and functional decline worldwide. Immunosenescence and environmental exposures increase susceptibility to infection and reduce vaccine effectiveness in this population. Respiratory viruses, including influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus, account for a substantial share of this burden, much of which is vaccine-preventable. However, their impact on functional decline and recovery in older adults remains insufficiently characterized. This international study aims to assess the effect of hospitalization for major respiratory viral infections on loss of autonomy in individuals aged 60 years and older, to inform targeted prevention and vaccination strategies.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Infections in Old Age

Detailed Description

The prevention of infectious diseases in older adults represents a major public health challenge due to their substantial impact on morbidity, mortality, and loss of functional capacity. Acute respiratory infections are among the leading causes of hospitalization and death in this population worldwide.

Ageing is associated with a progressive decline in immune function, resulting in increased susceptibility to infections and reduced vaccine effectiveness. In addition, environmental factors such as residence in collective living settings and repeated exposure to healthcare environments further increase the risk of exposure to and transmission of infectious agents.

The pathogens most frequently involved include respiratory viruses namely influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus as well as bacterial pathogens, particularly Streptococcus pneumoniae, and certain fungal agents. A substantial proportion of these infections are potentially preventable through vaccination.

Despite advances generated by the European IMI VITAL project and the AEQUI case-control study, data remain limited regarding the functional consequences of acute respiratory infections in older adults, particularly their impact on dependency, frailty, and post-infectious recovery.

This international study aims to address these knowledge gaps by evaluating the impact of hospitalizations related to influenza, SARS-CoV-2, respiratory syncytial virus, and human metapneumovirus on loss of autonomy in individuals aged 60 years and older. The findings are expected to strengthen the scientific evidence base needed to inform targeted vaccination and prevention strategies, ultimately contributing to healthier ageing.

• Study Type: Observational
• Enrollment (Estimated): 1600

Contacts and Locations

• Study Contact: Name: Gaetan GAVAZZI, MD,PhD; Phone Number: 0033(0)476766760; Email: GGavazzi@chu-grenoble.fr
• Study Contact Backup: Name: Saber TOUATI, PhD; Phone Number: 0033(0)476765805; Email: stouati1@chu-grenoble.fr

Study Locations

• France
  • Amiens, France
    • Active, not recruiting
    • University Hospital of Amiens
  • Melun, France
    • Recruiting
    • Melun Hospital
    • Contact: Sylvain DIAMANTIS, MD
  • Paris, France
    • Active, not recruiting
    • Villeneuve Saint Georges Hospital
  • Poitiers, France
    • Active, not recruiting
    • University hospital of Poitiers
  • Reims, France
    • Active, not recruiting
    • University Hospital of Reims
  • Tours, France
    • Active, not recruiting
    • University hospital of Tours
• Germany
  • Bayreuth, Germany
    • Not yet recruiting
    • Klinikum Bayreuth, Klinik für Geriatrie
    • Contact: Hans-Jürgen Heppner, MD PhD
  • Göttingen, Germany
    • Not yet recruiting
    • Abteilung Geriatrie Universitätsmedizin Göttingen, Abteilung Geriatrie
    • Contact: Christine Von Arnim, MD PhD
  • Jena, Germany
    • Not yet recruiting
    • Uniklinikum Jena, Klinik für Geriatrie
    • Contact: Kristin Häseler-Ouart, MD
  • Mannheim, Germany
    • Not yet recruiting
    • Universitätsmedizin Mannheim, IV. Medizinische Klinik (Geriatrie)
    • Contact: Heinrich Burkhardt, MD PhD
  • Ulm, Germany
    • Not yet recruiting
    • Klinikum Ulm, Geriatrisches Zentrum Agaplesion Bethesda
    • Contact: Michael Denkinger, MD PhD
• Italy
  • Bari, Italy
    • Not yet recruiting
    • University of Bari, Bari
    • Contact: Francesco Di Gennaro, MD
  • Catanzaro, Italy
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria "Renato Dulbecco", Catanzaro
    • Contact: Elvira Bonacci, MD
  • Rovigo, Italy
    • Not yet recruiting
    • ULSS 5 Polesana, Rovigo
    • Contact: Pierluigi Dal Santo, MD
  • Sanremo, Italy
    • Not yet recruiting
    • ASL 1 Imperiese, Sanremo
    • Contact: Giovanni Cenderello, MD
  • Torino, Italy
    • Not yet recruiting
    • Città di Torino, Torino
    • Contact: Antonino Maria Cotroneo, MD
  • Trento, Italy
    • Not yet recruiting
    • APSS Trento, Geriatria, Trento
    • Contact: Anna Casanova, MD
  • Trieste, Italy
    • Not yet recruiting
    • ASUGI, Trieste
    • Contact: Michela Zanetti, MD
  • Venice, Italy
    • Not yet recruiting
    • ULSS 3 Serenissima, Venice
    • Contact: Ernesto Rampin, MD
  • Verona, Italy
    • Not yet recruiting
    • ULSS 9 Scaligera, Legnago, Verona
    • Contact: Margherita Azzini, MD
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clínic Barcelona Servicio de Geriatría
    • Contact: Juan Manuel Pérez Castejón, MD
  • Madrid, Spain
    • Not yet recruiting
    • Hospital Universitario Ramón y Cajal. Madrid Servicio de Geriatría
    • Contact: Alfonso J. Cruz Jentoft, MD
  • Murcia, Spain
    • Not yet recruiting
    • Hospital Universitario Virgen de la Arrixaca Murcia Servicio de Geriatría
    • Contact: Juan Dionisio Avilés Hernández, MD
• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester School of Medicine, Infectious Diseases Unit
      • Contact: Edward Walsh, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population will include participants aged 60 years or older who are hospitalized with a serious acute respiratory infection in the departments of infectious diseases, geriatrics, internal medicine, pulmonology, or emergency medicine. Recruitment will be conducted by investigator physicians in each participating department. Potentially eligible participants will be identified by daily screening of admission records and results from standard of care respiratory samples.

Each country will aim to recruit approximately 320 participants - 80 with each pathogen of interest. Efforts will be made to secure an equal distribution of participants aged 60-75 and >75 years age.

Description

Inclusion Criteria:

• Male or female subjects aged 60 years or older
• Hospitalized in a study center (emergency department, infectious disease, internal medicine or geriatric hospital wards…) for acute respiratory infection (refer to table 1 below for definition).
• Confirmed positive PCR test for influenza, SARS-CoV-2, RSV, or human metapneumovirus (hMPV). Participants with co-infections with other viral or bacterial agents can be included.

Exclusion Criteria:

• Participants with conditions significantly impacting short-term functional status, such as severe disability (ADL score ≤2 or Clinical Frailty Scale ≥7), terminal illness, palliative care needs, or inability to comprehend and complete study questionnaires due to severe stroke sequelae, complete sensory loss, advanced dementia, or similar impairments.
• Participants that refuse or are unable to answer the 3- and 6-months follow-up phone call assessments
• Positive laboratory test for single (mono-infection) virus other than influenza, SARS-CoV-2, RSV, or human metapneumovirus (HMPV)
• Participant in exclusion period for another study using an investigational / unapproved medicinal product.
• Participant referred to in articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons : pregnant woman, parturient, breastfeeding mother, person deprived of liberty by judicial or administrative decision, persons undergoing psychiatric care under articles L.3212-1 and L.3213-1 who do not fall under article L.1121-8, persons admitted to a healthcare or social institution for purposes other than research, minors, person under legal protection or unable to express consent).
• Individuals opposed to participating in the research
• Staff members with a hierarchical relationship to the principal investigator

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of Functional Dependency assessed by Activities of Daily Living (ADL) Score	Change in functional performance measured using the Activities of Daily Living (ADL) scale. The ADL score ranges from 0 to 6, where higher scores indicate better functional independence The ADL score ranges from 0 to 6, where higher scores indicate better functional independence.	Baseline, at hospital discharge, 3 months after discharge, and 6 months after discharge.
Evolution of Functional Dependency assessed by Instrumental Activities of Daily Living (IADL) Score	Change in functional performance measured using the Instrumental Activities of Daily Living (IADL) scale. The IADL score ranges from 0 to 8, where higher scores indicate better functional independence.	Baseline, Day 7, 3 months after discharge, and 6 months after discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Status depending on Viral Etiology Assessed by Activities of Daily Living (ADL) Score	Change in functional status measured using the Activities of Daily Living (ADL) scale. The ADL score ranges from 0 to 6, where higher scores indicate better functional independence. Changes in score will be assessed between baseline, hospital discharge, 3 months, and 6 months, and stratified by viral etiology (SARS-CoV-2, influenza, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV)).	Baseline, Day 7, 3 months after discharge, and 6 months after discharge.
Functional Status depending on Viral Etiology Assessed by Instrumental Activities of Daily Living (IADL) Score	Change in functional status measured using the Instrumental Activities of Daily Living (IADL) scale. The IADL score ranges from 0 to 8, where higher scores indicate better functional independence. Changes in score will be assessed between baseline, hospital discharge, 3 months, and 6 months, and stratified by viral etiology (SARS-CoV-2, influenza, respiratory syncytial virus (RSV), and human metapneumovirus (hMPV)).	Baseline, Day 7, 3 months after discharge, and 6 months after discharge.
Medical Complications during and after hospitalization	Occurrence of medical complications during hospitalization and up to 6 months after discharge, including new diagnoses identified during follow-up.	From hospital admission to 6 months after discharge.
Health Care Resource Utilization (HCRU)	Health care resource utilization, including hospital length of stay, intensive care unit (ICU) admission during index hospitalization, and hospital readmissions occurring between discharge and 6 months.	From hospital admission to 6 months after discharge.
Length of Hospital Stay	Duration of the index hospitalization, measured in days, calculated from hospital admission (Day 1) to hospital discharge.	3 months after discharge
Intensive Care Unit (ICU) Admission	Proportion of participants admitted to an intensive care unit during the index hospitalization.	3 months after hospital discharge.
Hospital Readmissions After Discharge	Occurrence of hospital readmissions between discharge and 6 months after discharge.	From at hospital discharge to 6 months after discharge.
New Medications Initiated	Initiation of new drug treatments during hospitalization or within 6 months after discharge.	From hospital admission to 6 months after discharge.
Discharge Location after Hospitalization	Location at hospital discharge (e.g., home, rehabilitation facility, long-term care facility).	3 months after hospital discharge.
Living Situation at 6 Months after Discharge	Living situation of participants at 6 months after hospital discharge	6 months after hospital discharge.
Demographic Characteristics of Participants	Baseline demographic characteristics of participants, including age and sex.	Baseline.
Living Situation at Baseline	Living situation of participants prior to hospital admission.	Baseline.
Prevalence of Comorbidities	Prevalence of pre-existing comorbidities at baseline.	Baseline.
Vaccination Status	Proportion of participants vaccinated against influenza, SARS-CoV-2, and respiratory syncytial virus (RSV).	Baseline.
Time since last vaccination	Time elapsed since the most recent vaccination against influenza, SARS-CoV-2, or RSV, measured in months.	Baseline.
Pneumonia Severity Index (PSI) Score	Severity of pneumonia assessed using the Pneumonia Severity Index (PSI) score at hospital admission.	Baseline

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): January 15, 2028
• Study Completion (Estimated): June 15, 2028

Study Registration Dates

• First Submitted: December 29, 2025
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: respiratory infection; elderly people; functional dependency
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 38RC25.0367

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No